Controlled evacuation ostomy device with external seal

ABSTRACT

A flexible membrane is situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/881,055filed Mar. 26, 2004 which is a continuation of application Ser. No.10/107,998 filed Mar. 27, 2002, now U.S. Pat. No. 6,723,079.

STATEMENT REGARDING FEDERALLY SPONSORED RESEACH OR DEVELOPMENT

Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

Not Applicable

BACKGROUND OF THE INVENTION

(1) Field of the Invention

The present invention relates to ostomy devices of the type adapted tobe adhesively affixed to the skin surrounding the stoma and moreparticularly to such a device which includes external means forcontrolling evacuation by sealing the stoma while exerting only aminimum amount of sealing pressure.

Certain surgical procedures known as colostomy, ileostomy and urostomyresult in an opening in the abdominal wall, called a stoma, whichpermits waste discharge from the interior of a body cavity. Since thepatient has no control over the waste discharge, it is often necessaryfor the patients who have undergone these surgical procedures to utilizean ostomy device to protect the stoma and collect the waste material asit is discharged.

Over the years, ostomy devices of a variety of different types andconstructions have been utilized. Various materials and adhesives havebeen developed to increase the utility and wareability of the devices.

(2) Description of Related Art

The basic ostomy device includes a collection receptacle or pouchconnected to an adhesive coated faceplate which serves to mount thepouch to the body. The pouch includes first and second thin film wallswhich are sealed by heat welding or the like along the periphery. Thepouch has an inlet opening designed to be aligned with the stoma and anoutlet for emptying material from the pouch. In single piece devices,the pouch is permanently affixed to the adhesive coated faceplate. Intwo piece devices, the pouch is detachably mounted to the faceplate bycoupling rings or the like, permitting the pouch to be replaced withoutremoval of the faceplate each time.

The two piece device requires a means for releasably mounting the pouchto the faceplate. One particularly successful structure takes the formof a pair of annular or ring-like rigid or semi-rigid plastic parts, onein the form of an axially extending rib and the other in the form of achannel into which the rib may be removably received and frictionallyengaged.

These ostomy devices collect waste as it is discharged but include nomeans for controlling when discharge takes place. One of the mainobjectives of these devices is to increase the freedom of mobility ofthe wearer and thus the wearer's ability to lead a normal life byparticipating in various activities. However, having discharge takeplace into the collection pouch in certain situations may causeembarrassment to the wearer because of the noise or smell or because ofthe increase in the size of the pouch.

Accordingly, it is desirable to control when evacuation takes place sothat it does not occur at times which may cause embarrassment. Since thepatient has no means to control waste discharge, it is desirable toprovide a mechanical means by which waste discharge can be managed. Oneway to do this is to temporarily seal the stoma opening so as to preventdischarge when the seal is present. Once the seal is removed, evacuationof the bowel can take place.

However, an important concern in the management of stomas is to avoidexerting excess local pressure on the mucosal tissue. High localpressure can damage the stoma. Further, it can prevent blood flow to thetissue if the applied pressure exceeds capillary pressure. Thus, anyacceptable evacuation control device must seal the stoma exertingharmful pressure on the stoma or surrounding tissue.

BRIEF SUMMARY OF THE INVENTION

The seal, which forms the subject of the invention, is designed to bemounted externally and to exert a low pressures (preferably between 10mm Hg and 30 mm Hg) across the entire face of the stoma. The seal itselfis formed of a thin and flexible membrane. The membrane is preferablymade of a material with good barrier properties. One possible candidatematerial is the film used in the manufacture of ostomy pouches. Under aminimal amount of external pressure, the membrance drapes itself acrossand around the stoma, covering most surface irregularities. Based onpreliminary laboratory test results, the device can prevent release ofstool from the bowel with internal bowel pressure of 50 mm Hg and above.

Such a seal would adapt itself to a variety of stoma sizes and shapes.It would also be, by design, a slightly “imperfect” seal, so that itwould block the release of solid or semi-solid matter but would allowgas to escape. The ability of the seal to permit gas to escape isimportant to the management of waste in the bowel, since at any giventime more than two-thirds of the volume in the bowel is gas. Releasinggas in a controlled way minimizes discomfort and maximizes the timebetween evacuations.

The tissue surrounding the stoma may be very sensitive. It is thereforealso important that only minimal activation pressure be required tocreate the seal.

Further, it is desirable that the sealing device be interchangeable witha standard two-piece ostomy device collection pouch. In this way, thesealing device can be coupled to a standard two-piece ostomy devicecollection pouch. In this way, the sealing device can be coupled to astandard two-piece ostomy device faceplate, eliminating the necessity ofremoving an appliance that is adhesively attached to the skin after eachevacuation and hence the damage to the skin inherent in such repeatedremovals.

It is, therefore, a prime object of the present invention to provide acontrolled evacuation ostomy device which includes an external seal.

It is another object of the present invention to provide a controlledevacuation ostomy device with an external seal which exerts a minimumamount of sealing pressure on the mucosal tissue.

It is another object of the present invention to provide a controlledevacuation ostomy device with an external seal which permits the releaseof gas from the bowel while preventing the discharge of solid orsemi-solid materials.

It is another object of the present invention to provide a controlledevacuation ostomy device with an external seal which requires minimumpressure to create the seal.

It is another object of the present invention to provide a controlledevacuation ostomy device with an external seal which is compatible withstandard two-piece ostomy devices.

In accordance with one aspect of the present invention, an ostomy deviceis provided including a thin, flexible membrane. Means are provided forsecuring the membrane to the tissue surrounding the stoma. Means arealso provided for pressing the membrane against the stoma to seal thestoma.

The membrane has an edge. The securing means includes an adhesive layeron the membrane edge.

The pressing means includes a member situated over and sealed to themembrane. The member and the membrane define an internal chamber. Thechamber can be pressurized to press the membrane against the stoma.Means are provided for pressurizing the internal chamber.

In accordance with another aspect of the present invention, an ostomydevice is provided including a member formed of a wall with an edge.Means are provided for adhering the edge of the wall to the tissuesurrounding the stoma. Sealing means are situated within member,proximate the stoma. The sealing means has a first surface and a secondsurface. The sealing means defines a chamber within the member interior,between its first surface and the wall. The chamber can be pressurizedto press the second surface of the sealing means against the stoma.

The sealing means comprises a flexible membrane. The membrane has anedge. The membrane edge is fixed to the interior surface of the member.The membrane also preferably includes one or more circumferentialpleats.

The device includes means for pressurizing the chamber. The pressurizingmeans includes means in the member wall for permitting the entrance offluid, such as air, into the chamber. The entrance means includes aninlet port and a one way valve.

The pressurizing means may include an external pump device.Alternatively, it may include a pump device integral with the member.

The integral pump device includes a flexible wall affixed to the member.The flexible wall defines a chamber external to the member. The volumeof the external chamber can be reduced by the application of pressure onthe flexible wall. The entrance port connects the external pump cavityand the internal chamber of the member.

Means are provided for limiting the pressure introduced into theinternal chamber of the member. The pressure limiting means includes apressure relief valve.

The sealing means defines a second internal chamber between its secondsurface and the member wall. Means are provided for venting the secondinternal chamber. The venting means includes an outlet port.

The venting means may also include gas filtration means. The filtrationmeans includes a filter element operatively imposed between the secondinternal chamber and the outlet port. Any one of a variety of activatedcarbon filter formulations and constructions, including the use ofprotective microporous membranes, can be considered appropriate for usein this regard.

The member wall edge sealing means includes means for engaging the edgeof the member wall and means for adhering the edge engaging means to thetissue surrounding the stoma. The edge engaging means may include meansfor removeably engaging the edge of the member.

The device may be designed for use in combination with waste collectionmeans, such as a waste collection pouch. The waste collection means issituated between the member wall and the edge sealing means. The wastecollection means may be collapsible, preferably with a concertina-likeconfiguration.

The waste collection means may include a collection pouch with first andsecond flexible walls sealed around the periphery. The walls are fixedbetween the member and the edge sealing means, respectively.

The collection pouch may be elongated. Means for storing the pouchproximate the member may be provided.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

To these and such other objects which may hereinafter appear, thepresent invention relates to a controlled evacuation ostomy device withan external seal, as set forth in the following specification andrecited in the annexed claims, taken together with the accompanyingdrawings, wherein like numerals refer to like parts, and in which:

FIG. 1 is an exploded view of the device of the present invention in itssimplest form.

FIG. 2 is an exploded view of the cap member, sealing membrane andadhering means of a first preferred embodiment of the ostomy device ofthe present invention;

FIG. 3 is a side cross-sectional view of a first preferred embodiment ofthe present invention, as it would appear mounted over a stoma andpressurized.

FIG. 4 is a side cross-sectional view of the embodiment of FIG. 3, withan external pump in place;

FIG. 5 is a side cross-sectional view of a second preferred embodimentof the present invention, as it would appear mounted over a stoma andpressurized;

FIG. 6 is a side cross-sectional view of a third preferred embodiment ofthe present invention, as it would appear mounted over a stoma andpressurized;

FIG. 7 is an enlarged view of a pressure relief valve;

FIG. 8 is a side cross-sectional view of a fourth preferred embodimentof the present invention, as it would appear mounted over a stoma andpressurized;

FIG. 9 is an enlarged cross-sectional view of a portion of theembodiment of FIG. 8, showing the gas filtration member;

FIG. 10 is an exploded cross-sectional view of a fifth preferredembodiment of the present invention;

FIG. 11 is an exploded cross-sectional view of a sixth preferredembodiment of the present invention;

FIG. 12 is a cross-sectional view of a portion of the embodiment of FIG.11 showing the collection pouch in the contracted state;

FIG. 13 is a side cross-sectional view of a seventh preferred embodimentof the present invention, as it would appear mounted over a stoma andpressurized;

FIG. 14 is a side cross-sectional view of a portion of the embodiment ofFIG. 13 with the cap/pouch member detached from the faceplate; and

FIG. 15 is an exploded isometric view of the embodiment of the inventionshown in FIG. 13, showing the pouch in extended position and, inphantom, in the rolled position.

DETAILED DESCRIPTION OF THE INVENTION

As illustrated in FIG. 1, the present invention in its simplest formcomprises a thin, flexible membrane, generally designated A and adisc-like cover member, generally designated B. Member B includes a port11. A plug 13 is provided to seal port 11.

Membrane A has a cup shape with a closed bottom and an outwardlyextending top flange 15. A layer of adhesive 17 is situated on the rim19 of the bottom of the membrane to seal the membrane to the tissuesurrounding the stoma.

A second layer 21 of adhesive is placed on flange 15 so as to sealmember B to flange 15. Between membrane A and member B is a definedinternal chamber 23.

Chamber 23 is pressurized by forcing air or other fluid through port 11.This can be accomplished by using an external pump device, not shown inthis figure. Once the chamber is pressurized to the desired degree, theport is sealed by plug 13. The pressure within the chamber causesmembrane A to press against the stoma to seal the stoma opening.

As seen in FIGS. 2-4, the first preferred embodiment of the presentinvention includes a flexible sealing membrane generally designated A′adapted to cover and seal the stoma. Sealing membrane A′ is situatedwithin a cap-like member, generally designated B′, which surroundsmember A′. Cap member B′ is temporarily affixed to the tissuesurrounding the stoma by an adhesive means, generally designed C.

Sealing member A′ is preferably a round, thin, flexible membrane 10 withcircumferential pleats 12. The edge 14 of member 10 is fixed to theundersurface of the top wall 16 of cap B′. Cap B′ is made of rigid orsemi-rigid material. Cap B′ has a generally cylindrical sidewall 18 withan outwardly extending flange 20 extending from its bottom edge.

Although sealing membrane A′ is shown as a round thin, flexible membraneor diaphragm, it can be of any shape. Illustrated is one preferredshape, that of a “rolling diaphragm”, in which one or morecircumferential pleats 12 are formed. The pleats allow the seal to bestored in a small space, allow it to adjust to different stoma heights,and also allow it to be “presented” to the face of the stoma in anoptimal way for pressurization.

Membrane 10 can be made of a variety of thin, flexible plastic films. Anideal film would be thin, flexible, and possess good barrier properties.One such film would be a film used to fabricate ostomy pouches, althougha wide variety of films could be utilized.

Cap B′ is temporarily attached to the skin around the stoma by adhesivemeans C, preferably coated on the underside of a flexible wafer used inconventional ostomy devices and known as a faceplate. The adhesive canbe any skin compatible adhesive, many different formulations of whichare known in the art.

Thus, flange 20 of cap B′ is adhesively attached to the upper surface offaceplate 23. Faceplate 23 is temporarily attached to the tissue 22surrounding the stoma 24 by the adhesive coating on the undersurface offaceplate 23. Faceplate 23 has a central opening 25 through which thestoma extends.

Membrane 10 has a top surface 26 and a bottom surface 28. As best seenin FIG. 3, membrane 10 divides the interior of cap B′ into two chambers.The first chamber 30 is defined between the top surface 26 of themembrane and the undersurface of the top wall 16 of the cap. The secondchamber 32 is defined between the bottom surface 28 of the membrane, onthe one hand, and the upper surface of faceplate 23 and interior surfaceof sidewall 18 of the cap, on the other hand.

Top wall 16 of cap B′ is provided with an entrance port 34. One side ofa flap 36 is fixed to the underside of top wall 16, proximate port 34,and functions as a one-way or “check” valve. The check valve could haveany one of several embodiments, including “duckbill”, flap, or an“umbrella” valve configuration.

As seen in FIG. 4, an external hand pump 38 with a flexible bulb ofconventional design may be used to pressurize chamber 30, and thus pressmembrane 10 against the stoma. Pump 38 has a nozzle 40 designed to beinserted in port 34. Removal of nozzle 40 from port 34 permits flap 36to seal the port.

The seal created by the membrane 10 is, by design, not a perfect seal.Slight irregularities in the face of the stoma and/or slight wrinklesthat form in the seal material create very small leak paths. Inpractice, these leak paths are too small for solid or semi-solid stoolto pass, but allow any flatus that is present at the face of the seal tobe released. Since as much as two-thirds of the volume of the bowel iscomprised of flatus, release of flatus is important with respect to usercomfort and maximizing the time between evacuations.

Once flatus has been released past the seal, it is preferable for it tobe deodorized by means of a filtration element, as described below. Forexample, an activated carbon filter identical to those used in ostomypouches may be used for this purpose.

Vent port 42 is formed through cap sidewall 18 connecting chamber 32with the exterior of the cap. Gas released from the stoma into chamber32 due to the irregularities in membrane 10 is routed through port 42 tothe cap exterior.

Another way to pressurize the seal is by means of a flexible diaphragmpump built into the cap member itself as illustrated in FIG. 5. Theintegral pump would also incorporate a check valve 36 to prevent airfrom escaping from the seal. This could also be accomplished by anon-return valve similar to, but much smaller than, the non-return valvebuilt into a typical urostomy pouch.

As seen in FIG. 5, the integral pump can take the form of a dome-likeflexible part 44 fixed over top wall 16, defining a variable volumechamber 46. An opening 48 is formed through part 44, proximate the topthereof. To pressurize chamber 30, the user places his or her fingerover opening 48 and presses downwardly on part 44 decreasing the volumeof chamber 46 and forcing air through port 34. The finger is thenremoved, allowing part 44 to return to its original position, as chamber46 again fills with air. This action is repeated until sufficientpressure is built up in chamber 30 to seal membrane 10 over the stoma.

Limiting the pressure applied to the seal is an important concern, asnoted previously. One objective of the present invention is to ensurethat sealing pressure exerted on the bowel or stoma does not exceedlocal capillary pressure, to prevent necrosis of mucosal tissue. Thedevice therefore preferably includes a pressure relief valve that willopen at pressures exceeding a pre-set limit. An elastomeric “umbrella”valve can be employed for this purpose, but a variety of other reliefvalve configurations could be used, including a spring-loaded disc, aspring-loaded poppet, or a flexible membrane.

The preferred embodiment of FIG. 6 includes a somewhat smaller integralpump, similar in structure to the dome of FIG. 5, so as to provide roomin the cap top for a pressure relief valve 48 and a gas filter 50. FIG.7 illustrates the structure of a preferred embodiment of the reliefvalve 48, which has an “umbrella” like configuration. It consists of aflap 52 fixed to the cap by a stem 54. Flap 52 normally covers the ventports 42 in the top of the cap. Flap 52 is formed to have sufficientrigidity to prevent air from venting from chamber 30 until the airpressure in chamber 30 exceeds a predetermined pressure.

Filter 50, as best seen in FIG. 9, consists of a filter element 56,which may be formed of activated charcoal or any other filter material.The filter element is situated in housing 58 interposed between port 60on the top wall 16 of cap B′ and an exit port 62 in the top of housing58.

FIG. 8 illustrates another preferred embodiment, similar to that of FIG.6, except that integral pump dome part 44 is centrally located on thecap top and a second filter 56 is provided for increased venting.

Cap B′ can be attached directly to the skin surrounding the stoma usinga temporary adhesive similar to the adhesives used to attach a one-pieceostomy pouch to the skin, as illustrated in FIG. 1. Another means ofattachment is to affix the cap to a faceplate attached to the skin, asillustrated in FIGS. 2-6 and 8. Still another method is to engage thecap to a standard two-piece ostomy faceplate, as illustrated in FIGS.10, 11, 13 and 15. In those embodiments, the cap is preferably connectedto the faceplate in the same manner as a two-piece ostomy pouch. Itwould be interchangeable with two-piece ostomy pouches, so that the userwould have the option at any time to use the controlled evacuationdevice or a standard ostomy pouch, without the necessity of removing thefaceplate.

FIG. 10 illustrates a preferred embodiment, similar to that of FIG. 6,except that cap B′ and faceplate 23 are provided with interengagingparts such that the cap can be removed from the body without detachingthe faceplate.

In this embodiment, faceplate 23 is provided with an annular channel 64permanently attached to its exterior surface. Flange 20, which formedthe bottom edge of cap side wall 18 in previous embodiments, is replacedwith an annular protrusion or ring 66 which is adapted to be removablyreceived in channel 64. The exterior surface of ring 66 and the interiorsurface of channel 64 are provided with interlocking flexible parts,well known in the art, to insure that the ring is received within thechannel in a manner which creates a gas-tight seal. This method ofattaching the device to the wafer can be extended to other embodimentsemploying coupling means of a variety of configurations.

When the membrane seal is removed from the stoma, the contents of thebowel will be evacuated and must be collected and disposed of. One meansof facilitating collection and disposal is to incorporate a collectionpouch into the controlled evacuation device.

One possible pouch configuration would be a cylindrically shapedmembrane made of thin flexible plastic film, concentric with the centeraxis of the device. Such a membrane would be collapsed into a thinannular space for storage in the device. When evacuation is required,the user would detach the cap from the device, leaving a base componentstill attached to the ostomy faceplate. One end of the member would beattached to the cap, the other end to the base component. Removal of thecap would expand the pouch, much like the bellows of a concertina. Oncethe contents of the bowel are released to the pouch, the base componentwould also be removed from the faceplate and the entire device would bedisposed of in a suitable refuse container.

This is illustrated in FIG. 11. That figure shows a preferred embodimentof the present invention that is similar to that of FIG. 10 in that thecap is detachable from the faceplate, but differs in that itincorporates a thin walled collection pouch 68. Pouch 68 is generallycylindrical with openings at each end. One end of pouch 68 is attachedto the underside of the top wall 18 of cap B′. The other end of pouch 68is affixed to an annular base member 70 which carries engaging ring 66.As before, ring 66 is detachably received in channel 64 fixed to theexterior surface of faceplate 23.

Wall 18 of cap B′ is provided with an inwardly directed flange 72 whichis designed to lodge under an outwardly directed lip 74 which forms partof base member 70. While pressurized, cap B′ sits on base member 70,with flange 72 under lip 74. The wall of pouch 68 is collapsed like aconcertina, as seen in FIG. 12. When evacuation is to take place, flange72 is removed from under lip 74, cap B′ is moved away from faceplate 23,unsealing the stoma and expanding the pouch as the bowel is evacuatedinto the pouch. Base member 70 is then detached from faceplate 23 andthe cap/pouch/base assembly is disposed of. Other means of removablyattaching cap B′ to the base are possible, including a variety ofsnap-fit designs, frangible seals, “tear off” seals, and adhesive.

Other collection pouch configurations are also possible, including along, narrow sleeve-type pouch made of thin plastic film. One of thepouch panels would be attached to the base component, the other panelwould be attached to the cap. The cap would snap onto the base componentas before. The pouch could be rolled tightly up onto itself, much like abedroll, and stored adjacent to the cap.

When the user evacuates, the pouch would unroll or unfold from the basecomponent, and the pouch would fill with effluent. Once the pouch isfull, the base component would be removed from the faceplate and theentire device disposed of in an appropriate receptacle.

It would be possible to configure the cap to cover the pouch so that itwould not be visible until the cap is removed. In this embodiment, thecap could be molded in a soft material that would not adversely affectthe comfort of the user.

FIGS. 13, 14 and 15 illustrate another preferred embodiment of thepresent invention in which the collection pouch takes an elongated form,similar to a conventional collection pouch. The collection pouch isformed of top and bottom thin flexible walls 76, 78 heat sealed to eachother around the periphery 80. Each wall has a circular opening.

The portion of pouch wall 76 around the opening therein is fixed to apart 82, which is an extension of top wall 16 of cap B′. The portion ofpouch wall 78 around the opening therein is affixed to base 70, whichcarries engaging ring 66, which in turn is detachably received inchannel 64 on faceplate 23. When the device is in the sealed condition,the collection pouch is rolled up and retained proximate the cap, asseen in phantom in FIG. 14.

When the seal is released, the pouch is unrolled and discharge iscollected. Ring 66 of base 70 is then detached from channel 64 onfaceplate 23, as seen in FIG. 14, and the cap/pouch/base assembly isdiscarded. The faceplate remains in place and a new cap/pouch/baseassembly is mounted and pressurized to seal the stoma.

It will now be appreciated that the present invention relates to anostomy device which employs an external seal to control evacuation. Theseal is created by pressurizing a thin flexible membrane which coversthe stoma. The seal exerts a minimum of pressure on the tissuesurrounding the stoma and is activated without the application of forcesufficient to damage sensitive tissue or cause discomfort. Severalembodiments are disclosed, including devices with integral pumps, reliefvalves, gas filters and integral collection pouches of cylindrical andelongated configurations.

While only a limited number of preferred embodiments of the presentinvention have been disclosed for purposes of illustration, it isobvious that many modifications and variations could be made thereto. Itis intended to cover all of the modifications and variations which fallwithin the scope of the present invention, as defined by the followingclaims:

1. An ostomy device for sealing a stoma, said device comprising means,situated entirely externally to the body, for covering the stoma, andmeans for securing said stoma covering means over the stoma andpressurizable means situated over said stoma covering means to presssaid stoma covering means against the stoma to seal the stoma.
 2. Thedevice of claim 1 wherein said stoma covering means has an edge andwherein said securing means comprises an adhesive layer on said edge. 3.The device of claim 1 wherein said securing means comprises a membersituated over and sealed to said stoma covering means said membercomprising said pressurized means so as to define a recess that can bepressurized to press said stoma covering means against the stoma.
 4. Thedevice of claim 3 wherein said pressurizable means comprises a recessand further comprising means for pressurizing said recess.
 5. The ostomydevice of claim 1 wherein said stoma covering means comprises a flexiblemember.
 6. The device of claim 5 wherein said pressurizing means issituated over and sealed to said member so as to form an internalchamber which can be pressurized to press said member against the stoma.7. The ostomy device of claim 6 further comprising a cap formed of awall with an edge, means for adhering said edge to the tissuesurrounding the stoma, said member being situated within said cap,proximate the stoma, said member defining an internal chamber with saidcap, said internal cavity comprising said pressurizable means.
 8. Thedevice of claim 7 wherein said member has an edge, said edge being fixedto the interior of said cap.
 9. The device of claim 8 wherein saidpressurizing means comprises means in said cap for permitting entranceof fluid into said internal cavity.
 10. The device of claim 9 whereinsaid means in said cap for permitting the entrance of fluid into saidinternal cavity comprises an inlet port and a one-way valve associatedwith said inlet port.
 11. The device of claim 10 wherein saidpressurizing means comprises flexible means affixed to said cap, saidflexible means defining an external chamber the volume of which can bereduced by the application of pressure on said flexible means and anentrance port connecting said external chamber and said internalchamber.
 12. The device of claim 7 further comprising means for limitingthe pressure in said internal chamber.
 13. The device of claim 12wherein said pressure limiting means comprises a pressure relief valve.14. The device of claim 7 wherein said sealing means defines a secondinternal chamber with said cap wall, and means for venting said secondinternal chamber.
 15. The device of claim 7 for use in combination withwaste collection means.
 16. The device of claim 15 wherein said wastecollection means comprises a collection pouch.
 17. The device of claim15 wherein said waste collection means is collapsible.